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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K243158
Device Name TeraRecon Aorta.CT (1.1.0)
Applicant
Terarecon,Inc.
4309 Emperor Blvd.
Suite 310
Durham,  NC  27703
Applicant Contact Michael Sosebee
Correspondent
Terarecon,Inc.
4309 Emperor Blvd.
Suite 310
Durham,  NC  27703
Correspondent Contact Michael Sosebee
Regulation Number892.2050
Classification Product Code
QIH  
Date Received09/30/2024
Decision Date 01/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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